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Endocardial Stem Cells Approach Efficacy (ESCAPE)

Primary Purpose

Myocardial Ischemia

Status
Completed
Phase
Phase 3
Locations
Russian Federation
Study Type
Interventional
Intervention
Autologous bone marrow mononuclear stem cells or peripheral blood stem cells
Sponsored by
Meshalkin Research Institute of Pathology of Circulation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Ischemia

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Men and women who are not of childbearing potential
  • Age 21-75 years.
  • Patients with CAD, NYHA and CCS angina III-IV functional class
  • LVEF less than 35% measured by echocardiography or SPECT within three months of study entry
  • Unsuitable for initial or repeated conventional revascularization (CABG or PCI)

Exclusion Criteria:

  • Failure to provide informed consent.
  • Plan for PCI or CABG.
  • Non-cardiac illness with a life expectancy of less than 3 year.
  • Conditions/circumstances likely to lead to poor treatment adherence (e.g., history of poor compliance, alcohol or drug dependency, psychiatric illness, no fixed abode).
  • Previous heart, kidney, liver, or lung transplantation.
  • Current participation in another clinical trial in which a patient is taking an investigational drug or receiving an investigational medical device.
  • Recent acute myocardial infarction (AMI) within 90 days of study entry
  • Successful coronary revascularization (СABG or PCI) within 12 months of study enrollment
  • History of moderate to severe aortic stenosis or prosthetic aortic valve
  • Permanent atrial fibrillation
  • Thrombosis in LV, based on echocardiography data

Sites / Locations

  • State Research Institute of Circulation Pathology

Outcomes

Primary Outcome Measures

Null Hypothesis (Ho): There is no survival benefit in the stem cells group compared to the control group ( isolate MED therapy). H0: Ө ≤ 1 Alternative Hypothesis (Ha): There is a survival benefit in the stem cells group. HA: Ө > 1

Secondary Outcome Measures

Full Information

First Posted
February 10, 2009
Last Updated
April 23, 2012
Sponsor
Meshalkin Research Institute of Pathology of Circulation
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1. Study Identification

Unique Protocol Identification Number
NCT00841958
Brief Title
Endocardial Stem Cells Approach Efficacy
Acronym
ESCAPE
Official Title
Efficacy of the Endocardial Stem Cells Implantation in Ischemic Heart Failure Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meshalkin Research Institute of Pathology of Circulation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objective of this study is to test that endocardial stem cells implantation in patients who have CAD, low ejection fraction and signs of HF without possibility of CABG and PCI or despite on previous revascularization improves long-term survival compared to MED alone

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Ischemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Autologous bone marrow mononuclear stem cells or peripheral blood stem cells
Intervention Description
Cells concentration is 150х106 cells/ml (2ml) with CD34+ cells=2.5±1.44%
Primary Outcome Measure Information:
Title
Null Hypothesis (Ho): There is no survival benefit in the stem cells group compared to the control group ( isolate MED therapy). H0: Ө ≤ 1 Alternative Hypothesis (Ha): There is a survival benefit in the stem cells group. HA: Ө > 1
Time Frame
2007-2010

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women who are not of childbearing potential Age 21-75 years. Patients with CAD, NYHA and CCS angina III-IV functional class LVEF less than 35% measured by echocardiography or SPECT within three months of study entry Unsuitable for initial or repeated conventional revascularization (CABG or PCI) Exclusion Criteria: Failure to provide informed consent. Plan for PCI or CABG. Non-cardiac illness with a life expectancy of less than 3 year. Conditions/circumstances likely to lead to poor treatment adherence (e.g., history of poor compliance, alcohol or drug dependency, psychiatric illness, no fixed abode). Previous heart, kidney, liver, or lung transplantation. Current participation in another clinical trial in which a patient is taking an investigational drug or receiving an investigational medical device. Recent acute myocardial infarction (AMI) within 90 days of study entry Successful coronary revascularization (СABG or PCI) within 12 months of study enrollment History of moderate to severe aortic stenosis or prosthetic aortic valve Permanent atrial fibrillation Thrombosis in LV, based on echocardiography data
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evgeny A Pokushalov, MD, PhD
Organizational Affiliation
State Research Institute of Circulation Pathology
Official's Role
Principal Investigator
Facility Information:
Facility Name
State Research Institute of Circulation Pathology
City
Novosibirsk
ZIP/Postal Code
630055
Country
Russian Federation

12. IPD Sharing Statement

Citations:
PubMed Identifier
20560030
Citation
Pokushalov E, Romanov A, Chernyavsky A, Larionov P, Terekhov I, Artyomenko S, Poveshenko O, Kliver E, Shirokova N, Karaskov A, Dib N. Efficiency of intramyocardial injections of autologous bone marrow mononuclear cells in patients with ischemic heart failure: a randomized study. J Cardiovasc Transl Res. 2010 Apr;3(2):160-8. doi: 10.1007/s12265-009-9123-8. Epub 2009 Sep 24.
Results Reference
result
Links:
URL
http://www.meshalkin.ru/
Description
State Research Institute of Circulation Pathology Official Site

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Endocardial Stem Cells Approach Efficacy

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